NCT06764290

Brief Summary

For stroke patients, a challenging, unfamiliar, and more difficult task may increase the likelihood of brain activation to stimulate recovery. Pedal walking and walking with eyes-covered are both difficult and challenging tasks for stroke patients. The investigators intend to study the biomechanics and neural mechanisms of challenging pedal walking and walking with eyes covered. Stroke participants will wear electroencephalogram electrode caps and perform three tasks: walking on a flat surface for 60 seconds, walking on pedal for 60 seconds, and walking with eyes covered for 60 seconds.

Trial Health

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Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Apr 2024

Shorter than P25 for all trials

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2024

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

April 10, 2024

Completed
9 months until next milestone

First Posted

Study publicly available on registry

January 8, 2025

Completed
22 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2025

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2025

Completed
Last Updated

January 8, 2025

Status Verified

January 1, 2025

Enrollment Period

10 months

First QC Date

April 10, 2024

Last Update Submit

January 1, 2025

Conditions

Keywords

Electroencephalographygait rehablitationchallenging task

Outcome Measures

Primary Outcomes (2)

  • Weight Phase Lag Index

    The Weighted Phase Lag Index (WPLI) is a measure used to quantify phase synchronization in electrophysiological data.Continuously measure the connectivity of the coupling of neural oscillatory activity in the brain, while being statistically more powerful in detecting changes in signal phase synchronization.The WPLI ranges from 0 to 1, with 0 indicating no phase synchronization and 1 indicating complete phase synchronization.

    The study was an observational cross-sectional study with data collected at the same time as the trial was being conducted, so the duration was 60 seconds

  • Relative power

    The electroencephalogram signal in the time domain is converted into the relevant information in the frequency domain, the frequency bands are divided, and the relative power results of each channel in each frequency band are derived. Among them, delta:1-4Hz, theta:4-8Hz, alpha:8-15Hz, beta:15-30Hz, gamma:30-45Hz.

    The study was an observational cross-sectional study with data collected at the same time as the trial was being conducted, so the duration was 60 seconds

Study Arms (1)

stroke participants

Stroke participants with residual abnormal gait.

Other: pedal walkingOther: visual occlusion

Interventions

Pedal walking is a challenging walking task that can be used as a form of physical therapy for stroke participants.

stroke participants

Walking with eyes-covered is a challenging walking task that can be used as a form of physical therapy for stroke participants.

stroke participants

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Stroke patients, including outpatients and inpatients.

You may qualify if:

  • First-time occurrence of stroke confirmed by computed tomography or magnetic resonance imagingClinical diagnosis of stroke
  • Disease duration of more than 14 days, less than 1 year
  • Able to walk independently but with a lingering abnormal gait

You may not qualify if:

  • Lesions accumulate in the brainstem
  • Lesions accumulate in the cerebellum
  • Impaired vision
  • Severe cognitive impairment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Geriatric Hospital of Nanjing Medical University, 269 Qingmen Street

Nanjing, Jiangsu, 210000, China

RECRUITING

Geriatric Hospital of Nanjing Medical University

Nanjing, Jiangsu, 210000, China

RECRUITING

Related Publications (3)

  • Krakauer JW. Motor learning: its relevance to stroke recovery and neurorehabilitation. Curr Opin Neurol. 2006 Feb;19(1):84-90. doi: 10.1097/01.wco.0000200544.29915.cc.

    PMID: 16415682BACKGROUND
  • Fettrow T, Hupfeld K, Tays G, Clark DJ, Reuter-Lorenz PA, Seidler RD. Brain activity during walking in older adults: Implications for compensatory versus dysfunctional accounts. Neurobiol Aging. 2021 Sep;105:349-364. doi: 10.1016/j.neurobiolaging.2021.05.015. Epub 2021 May 31.

    PMID: 34182403BACKGROUND
  • Kulkarni A, Cui C, Rietdyk S, Ambike S. Humans prioritize walking efficiency or walking stability based on environmental risk. PLoS One. 2023 Apr 7;18(4):e0284278. doi: 10.1371/journal.pone.0284278. eCollection 2023.

    PMID: 37027387BACKGROUND

Related Links

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Xia Li Zhang, doctor

    Geriatric Hospital of Nanjing Medical University

    STUDY DIRECTOR

Central Study Contacts

Jing Zhao, master

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Junior physiotherapist

Study Record Dates

First Submitted

April 10, 2024

First Posted

January 8, 2025

Study Start

April 1, 2024

Primary Completion

January 30, 2025

Study Completion

February 28, 2025

Last Updated

January 8, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will share

all IPD that underlie results in a publication.

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
Time Frame
Six months after publication.
Access Criteria
Request from the corresponding author by email.

Locations